Core B. Translational Regulatory Affairs and Medicinal Chemistry Project Abstract The Translational Regulatory Affairs and Medicinal Chemistry Core will serve as an essential resource for the project teams by creating a consolidated process for the preparation and submission of documents for regulatory review by local, state, and federal agencies; by expediting the approval of new clinical modalities; by providing guidance and referral on aspects of clinical chemistry and cGMP; by facilitating industry and institutional interactions; and by insuring the inventor(s)'s and institution's interests in novel discoveries are protected.